After 10 years in the making, the EU Regulation REACH (Registration, Evaluation and Authorisation of Chemicals) came into force this month and requires that 30,000 chemicals currently being used in the EU must now be registered and tested for damage to people, animals and the environment within the next 11 years. These regulations strike fear into the hearts of many industries, although the pharmaceutical industry is looking likely to emerge not only unscathed, but better off under the new rules.
In the past, all new chemicals used in the industry had to comply with the notification of new substance (NONS) package - a battery of tests, including in vitro skin and irritation studies on rabbits, rodents and fish, which generated data that needed to be presented when seeking approval to use a new chemical in Europe. However, under REACH, only new chemicals that are produced in quantities over 10 tonnes need to undertake such a comprehensive number of tests and virtually all quantities of chemicals produced and used by pharmaceutical firms do not fall into this category.
As a result, the pharmaceutical industry will have to actually undertake far fewer tests, including those on animals, than it does now, a spokesperson from contract research firm Huntingdon Life Sciences (HLS) told Outsourcing-Pharma.com. "REACH will bring great reductions in the level of testing required by the pharmaceutical industry, most intermediates will require no testing and requirements for chemicals in the 1 to 10 tonne level are markedly reduced when compared to NONS," said the spokesperson.
Meanwhile, it appears that pharmaceutical companies are not the only ones who will benefit under the new changes. For example, HLS is already experiencing an increase in the environmental regulatory consulting services it offers - a small (10 per cent), but emerging part of its business. "Companies need advice to understand the impact of this new legislation, with good relationships with the regulators and many years experience, HLS is currently designing and implementing REACH compliance strategies for many pharma and chemical companies," said the spokesperson.
"For 20 years we have been looking at the potential effects of chemicals on the environment and companies are now coming to us for advice in meeting the new regulatory requirements because their in-house teams are generally not experienced in the environmental field." Meanwhile, the bulk manufacturers and ingredients suppliers in the pharmaceutical industry may not be so lucky under REACH. Those that produce chemicals in quantities over 10 tonnes will be required to comply with the new laws and may be facing increasing testing burdens if existing environmental data on these chemicals is inadequate.
Generics manufacturers of mass market drugs such as paracetamol, aspirin, ibuprofen and metformin and those who bulk manufacture and ship large amounts of the more popular ingredients for the European market will be affected. Under the new legislation, producers of certain types of chemicals will be obligated to provide new animal testing data. Even so, such companies are now evaluating the extent to which they have to go to comply with the tightened regulations.
"The companies that are forced to comply will try and do as few additional tests as they possibly can," said the HLS spokesperson. "A lot of data already exists out there so it may be a case of compiling what is available and filling the existing data holes with additional tests, and using as few animals as possible if they have to use any at all."
A joint project between animal welfare charities (the Fund for the Replacement of Animals in Medical Experiments (FRAME)) and a group of large pharmaceutical companies has already been established in order to build a database which will allow other firms to share the results of new and existing chemical data obtained from animal testing in order to prevent the unnecessary repetition of such tests. This set up has already been proving "extremely successful" and it is hoped that companies affected by REACH will follow suit, a spokesperson for the Animal Defenders International (ADI) and the National Anti-Vivisection Society (NAVS) told Outsourcing-Pharma.com.
Meanwhile, HLS also said that it doesn't expect the amount of animal testing work it receives to change by much as a result of REACH, because the nature of the animal research it conducts is primarily focused on the medical side of new drugs, which requires more specialised, complex and costly tests than the more standard and basic tests that are required for environmental testing under REACH.